Sridhar Ramaswamy. GV
October 28, 2019 08:59 AM EDTUpdated 09:10 AM
People
Financing

Google’s ven­ture arm re­cruits a Har­vard/Tesaro vet to help plant the seeds for a sec­ond on­col­o­gy R&D rev­o­lu­tion

John Carroll

Editor & Founder

Oncology R&D has been exploding over the past 5 years, and now Google’s venture arm is preparing to place a few explosives to help with the revolution — relying on a new recruit in the Cambridge/Boston branch to assist in fostering the movement.

Eight months after the high-profile scientist and Agios founder David Schenkein started his third career act in biotech, teaming up with Krishna Yeshwant as a general partner in charge of the life sciences portfolio at GV, they’re bringing on board their second entrepreneur-in-residence to help strategize their approach to investing in cancer research. And he has some deep experience in the oncology field.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

SPONSORED
May 3, 2021 06:00 AM EDT

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

David Coman

Chief Executive Officer

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

May 5, 2021 06:29 AM EDTUpdated 07:17 AM
People
Startups

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Amber Tong

Senior Editor

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)
May 6, 2021 04:54 PM EDT
R&D

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

John Carroll

Editor & Founder

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, Getty
May 6, 2021 09:46 AM EDTUpdated 10:04 AM
Coronavirus
Manufacturing

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Zachary Brennan

Senior Editor

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

Nick Leschly at Endpoints' JPM20 Breakfast Panel (Jeff Rumans for Endpoints News)
May 6, 2021 06:26 AM EDTUpdated 06:47 AM
People

2sev­en­ty: Nick Leschly brings a trio of top ex­ecs with him on top-speed flight from the blue­bird nest

Amber Tong

Senior Editor

After serving more than a decade as bluebird bio’s chief bluebird, Nick Leschly is switching it up.

At some point this year, Leschly will officially become the CEO of 2seventy — the new company that will house bluebird’s oncology business while Andrew Obenshain, the current president for severe genetic diseases, will take over as CEO to oversee the rare disease pipeline remaining at bluebird.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

May 5, 2021 01:46 PM EDT
Pharma
FDA+

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

Zachary Brennan

Senior Editor

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

May 5, 2021 01:26 PM EDTUpdated 01:58 PM
Pharma
FDA+

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

Zachary Brennan

Senior Editor

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Cynthia Butitta (L) and Joe Jimenez
May 5, 2021 10:37 AM EDTUpdated 01:07 PM
People

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

John Carroll

Editor & Founder

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,800+ biopharma pros reading Endpoints daily — and it's free.

May 6, 2021 05:16 PM EDT
Pharma
FDA+

Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

Zachary Brennan

Senior Editor

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Google’s ven­ture arm re­cruits a Har­vard/Tesaro vet to help plant the seeds for a sec­ond on­col­o­gy R&D rev­o­lu­tion

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

2sev­en­ty: Nick Leschly brings a trio of top ex­ecs with him on top-speed flight from the blue­bird nest

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug